Nasdaq-listed CASI Pharmaceuticals ($CASI) filed a China FDA application to conduct a Phase II clinical trial in fibrolamellar carcinoma patients for proprietary drug candidate, ENMD-2076.
The company, which has R&D offices in Beijing, said in a press release that the Phase II trial in China will be an extension of a U.S. Phase II trial expected to start in the third quarter of this year.
The latest application in China follows March press releases to conduct a Phase II global clinical trial in ovarian clear cell carcinoma for the same candidate and an announcement of a Phase II trial of the same target therapy in triple-negative breast cancer at the Cancer Hospital of Chinese Academy of Medical Sciences in Beijing.
In September 2014, Spectrum Pharmaceuticals ($SPPI) licensed two of its cancer drugs, Zevalin and Marqibo, and a Phase III candidate to CASI to develop and sell in China.
"This is our fourth application to conduct a new drug clinical trial in China for ENMD-2076," said CASI CEO Ken Ren in a press statement.
"We received approval for our first three applications to conduct trials in ovarian clear cell carcinoma, soft tissue sarcoma, and triple negative breast cancer, the latter of which was initiated recently and is currently enrolling patients."
The company said the candidate ENMD-2076 has received patents in the U.S., China, Japan, Canada, and Australia among others countries for the orally active Aurora A/angiogenic kinase inhibitor.
- here's the CASI release